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Heart stent clogging again? new study tests best fix

NCT ID NCT04862052

Disease control Sponsor: Semmelweis University Heart and Vascular Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 108 people whose heart stents had narrowed again after being placed. Doctors tested three different devices: two types of drug-coated balloons and one new stent. The goal was to see which one works best to keep the artery open and prevent future heart problems. The results could help doctors choose the best treatment for this common issue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
drug-coated balloons (sirolimus or paclitaxel) and drug-eluting stents (everolimus)
What this could lead to
If one treatment proves clearly better, it could become the new standard for managing stent re-narrowing, reducing repeat procedures and heart attacks.
What could go wrong
This is a small, completed study (108 patients) with no blinding. Results may not apply to all patients, and differences between treatments might be small or due to chance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

108 people

The number who actually took part.

Started

Apr 2021

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients admitted for intervention of drug eluting stent restenosis * Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices * Optional enrollment in the optical coherence tomography sub-study (10-20% of patients) Exclusion Criteria: * Patients undergoing coronary angiography after sudden cardiac death * Pregnant or nursing

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Conditions

The condition(s) this trial relates to.

coronary restenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary stent restenosis

Contacts and locations

Locations

  • Semmelweis University Heart and Vascular Center

    Budapest, Budapest, 1122, Hungary

  • University of Szeged, Department of Invasive Cardiology

    Szeged, Csongád-Csanád, 6725, Hungary

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